11/08/2025
First Patient Included Marks Major Milestone in EU-Funded Clinical Trial
Copenhagen, Denmark, August 11, 2025 — PsyPal has reached a major milestone with the inclusion of its first patient in the multi-site clinical trial investigating psilocybin therapy for psychological and existential distress in people with progressive, life-limiting illnesses. The first patient has been included at University Medical Center Groningen (UMCG), Netherlands, one of four specialised clinical centres participating in this unprecedented, EU-funded initiative.
“This is a historic step,” says Prof. Dr. Robert Schoevers, head of psychiatry at the University Medical Center Groningen (UMCG) and principal investigator of PsyPal. “After many months of preparation, we are thrilled to begin working directly with patients.”
Funded by the European Union and coordinated by UMCG in the Netherlands, PsyPal is the first European Union-funded multi-site clinical trial on psilocybin therapy. Specifically, the trial will explore whether psilocybin, administered in a supportive psychotherapeutic context, can help reduce depression, anxiety, and improve quality of life in individuals living with chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or advanced and atypical parkinsonian disorders (APD).
“Too many people in need of palliative care endure overwhelming psychological and existential distress that conventional treatments often fail to address,” says Stephan Tap (UMCG), clinical trial manager. Ulf Bremberg (Osmond Labs), project manager, adds: “By combining psychotherapy with a novel compound like psilocybin, we hope to offer support that extends beyond symptom relief, into the deeply human realms of connection, meaning, and peace.”
Each clinical site focuses on one of the four targeted conditions:
● COPD – University Medical Center Groningen (UMCG), Netherlands
● APD – Champalimaud Foundation, Portugal
● MS – National Institute of Mental Health, Czech Republic
● ALS – University of Copenhagen and Bispebjerg Hospital, Denmark
The trial will eventually involve over 100 patients across Europe, each undergoing two therapy sessions with either a therapeutic dose (high-dose) of psilocybin or a non-therapeutic dose (low-dose) in a controlled clinical setting. This is the first time a psychedelic substance is being studied in a clinical trial targeting patients who have palliative care needs, other than for cancer, in Europe. Therefore, the first patient included in the PsyPal study marks the beginning of a new chapter in European mental healthcare research.
The study medication (psilocybin) and the entire supply chain process are fully supported by Avextra Pharma, a German research-oriented biotech company dedicated to researching and developing plant-based medicines. In collaboration with Avextra, the PsyPal consortium is dedicated to advancing the clinical understanding, accessibility, and evidence of psilocybin therapy for patients with significant needs across Europe.
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Disclaimer – PsyPal is funded by the European Union. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
